Kornimate/medical-research-clean huggingface dataset:
a rollover study of cc-122

Conditions: Non-Hodgkin Lymphoma

Summary: the purpose of the study is to provide cc-122 treatment to participants who have been receiving treatment in other cc-122 clinical trials investigating cc-122 for more than 5 years (cc-122-st-001 \[nct01421524\], cc-122-st-002 \[nct02509039\], cc-122-dbcl-001 \[nct02031419\], and cc-122-nhl-001 \[nct02417285\]), receiving clinical benefit from the treatment and to monitor the safety and tolerability of cc-122.


Eligibility criteria:
key inclusion criteria: * participant who is currently receiving cc-122 on another cc-122 clinical trial that has met its primary and secondary endpoints. * participant who has participated in previous cc-122 protocol (including cc-122-st-001 \[nct01421524\], cc-122-st-002 \[nct02509039\], cc-122-dbcl-001 \[nct02031419\], and cc-122-nhl-001 \[nct02417285\]), and is deemed by the investigator to be deriving benefit from cc-122 as defined by the previous protocol. * participant who is able to tolerate study therapy and has not yet experienced progressive disease or any treatment discontinuation criteria of the parent study. key exclusion criteria: * participant is not eligible for cc-122 treatment as per the parent study. * participants not receiving clinical benefit as assessed by the investigator. any clinical ae, laboratory abnormality, or intercurrent illness which, in the opinion of the investigator, indicates that participation in the study is not in the best interest of the participant. * women who are breastfeeding. note: other protocol-defined inclusion/exclusion criteria apply.

Keywords: cc-122 avadomide bms-986381 non-hodgkin lymphoma diffuse large b cell lymphoma follicular lymphoma chronic lymphocytic leukemia multiple myeloma
valproic acid for treatment of hyperactive or mixed delirium in icu

Conditions: Hyperactive Delirium; Mixed Delirium

Summary: delirium is the most often encountered psychiatric diagnosis in the general hospital, with incidence up to 85% in the intensive care unit (icu) setting and with significant consequences on patients' morbidity and mortality. currently, although not fda approved, antipsychotics are often considered the first-line pharmacological treatment. however, there can be limitations to their use, including side effects or lack of efficacy. valproic acid (vpa) is one of the alternatives at times used in such patients which from limited case series data appears to be helpful and tolerated. vpa can provide relief from agitation that poses a threat to the safety and recovery of the patient. moreover, mechanistically it addresses the neurochemical and cellular abnormalities inherent in delirium (it has nmda-antagonist, anti-dopaminergic, gabaergic,anti-inflammatory, anti-apoptotic, and histone deacetylase inhibitor properties, among others). the purpose of this study is to evaluate the efficacy and tolerability of the vpa in the first known to us randomized controlled trial.

the investigators plan to investigate the efficacy and tolerability of scheduled vpa as compared to placebo with as needed basis (prn) haloperidol (as a back-up in both arms) for treatment of hyperactive or mixed delirium. patients will be randomized to scheduled vpa or placebo (normal saline) and both arms will have flexible prn dosing of haloperidol. thus, the investigators plan to learn the time to delirium resolution in patients treated with vpa versus placebo; percentage of patients responding to vpa versus placebo; tolerability of vpa versus placebo. if addition of scheduled vpa proves to shorten time to delirium resolution as compared to placebo, lead to less use of haloperidol, and/or have fewer side effects, it would provide a very important addition to our limited evidence-based repertoire of delirium treatment. moreover, this pilot study would then pave the way for the bigger randomized control trial powered to detect its effect size.

Eligibility criteria:
inclusion criteria: * patients 18 years of age and older * admitted to surgical icu * diagnosed with hyperactive or mixed delirium exclusion criteria: * hypoactive delirium * primary team does not think patient is appropriate to participate * no oral access (po or ngt) * non-english speaking * contraindication to study medications * pregnant women or woman of child-bearing age not on documented contraception * qtc = or greater than 480 * hepatic dysfunction * decreased platelets or platelet dysfunction * bleeding disorder, current major bleeding * history of nms, epilepsy, or pd * diagnosis of schizophrenia, bipolar disorder or schizoaffective disorder * on warfarin or carbapenems * delirium due to alcohol withdrawal * treated with antipsychotics for more than 48 hours prior to study enrollment.

Keywords: hyperactive delirium mixed delirium anti-psychotic haldol valproic acid
the eminence study - pet/mr imaging of head neck cancer

Conditions: Head and Neck Neoplasms

Summary: head and neck cancers (hnc) often receive radiotherapy as part of their treatment. however, unacceptable failure rates and severe side effects remain a challenge. the improvements in radiotherapy are closely related to improvements in medical imaging. functional imaging, where intratumoural characteristics such as tumour oxygenation, metabolism, and blood vessel function can be quantified, offers possibilities to personalize the radiotherapy. in this study we will establish the clinical workflow for pet- and mri-based radiotherapy in hnc by acquiring images prior to and during radiotherapy to develop new concepts for image-based biologically adaptive radiotherapy, both based on photon-based radiotherapy and also proton therapy, which soon will be available for cancer patients in norway. the investigators aim to contribute towards further developments of personalised high-precision radiotherapy for hnc patients resulting in improved outcome, reduced side-effects and better quality of life.


Eligibility criteria:
inclusion criteria: * willing and able to give full written consent according to the protocol approved by the regional ethics committee * histologically confirmed squamous cell carcinoma in the head neck region (pharynx, larynx, oral cavity or sinonasal area) * locally advanced disease without sign of dissemination (t3/t4 and/or n1-3, m0) on diagnostic imaging * scheduled for definitive radiotherapy with curative intent with or without concomitant chemotherapy * adequate renal function: creatinine clearance ≥ 60 ml/minute * lymph node metastasis from cancer of unknown primary of the upper neck (i.e. level ii-iii) were pet/ct is negative outside the head-neck region can be considered for inclusion at the discretion of the study investigators. exclusion criteria: * general contraindications for mri (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia) * serious comorbidity (including previous or othe cancer) that in the opinion of the investigator would compromise the patient's ability to complete the study of interfere with the evaluation of the study objectives (e.g. poorly controlled diabetes mellitus) * histologically confirmed scc of same or other origin within the last five years * patient wants to withdraw for any reason during the study

Keywords: diagnostic imaging functional imaging nuclear magnetic resonance imaging positron-emission tomography radiotherapy
c-star movement database

Conditions: Stroke; Parkinson Disease; Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Below Knee (Injury)

Summary: the purpose of this study is to develop a database that contains movement and rehabilitation-related data collected through the use of wearable sensors and video. this database will serve as a resource for clinicians and researchers interested in the investigation of movement or rehabilitation-related research ideas.

scholarly research in the field of physical rehabilitation helps to aid in maximizing outcomes for individuals that require these services due to orthopedic and neurologic injuries. to produce quality research results, large cohorts of individuals are often required for data analysis. some research facilities or labs do not have adequate access to large cohorts or may not have the means to recruit them. by building the c-star database, the intent is to create a database that can serve as a hub for data sets that researchers and clinicians with appropriate access may use to support their research questions related to movement and physical rehabilitation.

Eligibility criteria:
inclusion criteria: 1. age 0 to 99 years old 2. able and willing to give written consent and comply with study procedures exclusion criteria: 1. unable to give written consent or comply with study procedures 2. any condition that would prevent safe completion of study activities, as determined by the principal investigator
study of split-course chemoradiotherapy for postoperative locoregional recurrence of non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this phase ii randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection

this phase ii randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection. patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with split-course thoracic radiotherapy of 40-51 gy/10-17 fractions and 15-24 gy/5-8 fractions administered in the first and second courses, respectively, with one-month break. the primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. progression-free survival will be calculated using the kaplan-meier method.toxicities will be graded according to ctcae v. 4.0.

Eligibility criteria:
inclusion criteria: * pathologic confirmation of nsclc. * patients have measurable or evaluable lesions based on the response evaluation criteria in solid tumors (recist) criteria. * postoperative locoregional recurrence including ipsilateral hemithorax and the mediastinum. * eastern cooperative oncology group (ecog) performance status 0-1. * previously treated with chemotherapy or treatment-naive * no previous chest radiotherapy, immunotherapy or biotherapy * hemoglobin≥10 mg/dl, platelet≥100000/μl,absolute neutrophil count ≥1500/μl * serum creatinine ≤1.25 times the upper normal limit(unl), or creatinine clearance≥60 ml/min * bilirubin ≤1.5 times unl, ast（sgot）≤2.5 times unl ,alt（sgpt）≤2.5 times unl,alkaline phosphatase ≤5 times unl * forced expiratory volume at one second (fev1) \>0.8 l * coagulation tests within normal limits * patients and their family signed the informed consents exclusion criteria: * previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ * second primary carcinoma of the lung * contraindication for chemotherapy * malignant pleural or pericardial effusion. * women in pregnancy, lactation period, or no pregnancy test 14 days before the first dos * women who has the probability of pregnancy without contraception * tendency of hemorrhage * in other clinical trials within 30 days * addicted in drugs or alcohol, aids patients * uncontrollable seizure or psychotic patients without self-control ability * severe allergy or idiosyncrasy * not suitable for this study judged by researchers

Keywords: non-small cell lung cancer split-course chemoradiotherapy locoregional recurrence postoperative recurrence
long term vascular changes in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Complications; Coronary Heart Disease

Summary: the main purpose of this study is to investigate progression of late complications of diabetes during the last ten years in a well characterized cohort of type 1 diabetes with a long duration of the disease, and to define factors responsible for the progression of late complications.

despite intensively research in the field of hyperglycaemia and coronary heart disease in type 1 diabetes it is still not known in detail how hyperglycaemia leads to damage of the vessels. the aims of the present proposal are therefore two-fold: 1. to study in detail the progression of atherosclerosis (and micro vascular complications) in a well characterized cohort of type 1 diabetes with a long duration of the disease. this project will be a continuation of the oslo study, a cohort started in 1982, with the last follow-up study in 1999/2000. 2. to define factors responsible for the progression of coronary heart disease (and micro vascular complications) in this cohort.

Eligibility criteria:
the original criteria from 1982: inclusion criteria: * age 18-45 years * diagnosis of type 1 diabetes at \ 7 but \< 30 years * c-peptide \< 0, 1 nmol/l exclusion criteria: * serum creatinine \> 150 µmol/l * diastolic blood pressure \<100mmhg * overt nephropathy * proliferative retinopathy * pregnancy * a history of neuropathy * other chronical disease * treatment with other drugs except insulin and oral contraceptives

Keywords: diabetes mellitus, type1 cardiovascular disease diabetes complications glycation end products, advanced
evaluation of the efficacy of growth hormone on healing of periapical pathosis

Conditions: Periapical Diseases; Growth Hormone; Non Surgical Debulking

Summary: this study aimed to evaluate the effect of growth hormone and non-surgical debulking of periapical tissues on healing of periapical pathosis

out of ninety patients, forty-eight healthy male patients aged 18 to 40 years old were selected from outpatients attending the endodontic clinic of the faculty of dental medicine, al-azhar university boys, cairo, egypt, to be included in this study. the selected patients have no medical contraindications for oral surgical procedures (scores1-2) according to the classification of the american society of anesthesiologists (asa)(8). maxillary permanent incisor teeth were selected according to specific inclusion criteria based on preoperative assessment of the patients.

Eligibility criteria:
inclusion criteria:- necrotic teeth with apical periodontitis. * teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade ii tooth mobility. * teeth with mature apices, root canal curvature between (0-10º) according to schneider(9) and radii of curvature between 2 to 5 mm according to pruett would be included in the study(10). * teeth with estimated working length of 20mm(±2mm) from the incisal edge as a reference point provided that the crown/root ratio was not compromised. * non-critical sized periapical lesion related only to one tooth of a 2 to 4mm diameter and score 3 when evaluated using the cone beam computed tomography periapical index score (cbctpai)(11) , table (1) presents the scoring scale of cbct-pai. * teeth located in anatomic areas in which enucleation of the periapical tissues may jeopardize nearby structures, such as the incisive foramen or nasal cavity should be at least 2 mm away from these structures. exclusion criteria: * necrotic teeth with related periapical swelling or sinus tract. * teeth with previous root canal fillings and /or indirect coronal restoration. * teeth with abnormal root canal anatomy. * non-restorable teeth due to insufficient coronal tooth structure. * teeth with periodontal disease. * teeth with grade iii mobility. * teeth with clinical evidence of a missing buccal bony plate over the periapical defect. * traumatized teeth with suspected root cracks, fractures, intrusive and extrusive injuries, previously avulsed or lateral luxation injuries.
reduction of post intravitreal injection bleeding and pain by ice

Conditions: Pain

Summary: intravitreal injections are an efficient method for delivering intraocular therapeutic agents in numerous ophthalmologic diseases. however, side effects, such as pain and subconjunctival hemorrhage remain a major concern. prevention or alleviation of those side effects might shorten the healing duration and improve patients' quality of life.

cooling the eye using ice patched prior to intravitreal injections may ameliorated pain and subconjunctival hemorrhage incidences.

Eligibility criteria:
inclusion criteria: patients receiving intravitreal injection exclusion criteria:
study of negative emotion, fear-avoidance belief and quality of life in patients with ankle sprain

Conditions: Chronic Ankle Sprain

Summary: this study intends to investigate the negative emotions, fear-avoidance beliefs, and quality of life in patients with chronic ankle sprains to explore the relationship between negative emotions such as anxiety and depression, fear-avoidance beliefs, and their impact on quality of life.

research design: this study is an observational study. it is planned to recruit a total of 120 patients with ankle sprain injury who meet the selection criteria from the rehabilitation department of peking university third hospital. they will be divided into an anxiety and depression group and a control group based on anxiety and depression scale. basic information, anxiety and depression scales, fear-avoidance beliefs score and quality of life score of two groups will be compared and analyzed.

Eligibility criteria:
inclusion criteria: * ankle sports injury time\> 6 months; * age 18-50 years; * no pain in daily activities, or a numerical rating scale (nrs) 6 points or less; * no mechanical instability of the ankle joint and obvious restriction in joint movement ; * agree to participate in this study. exclusion criteria: * acute inflammation of lower limb joints; * new or unhealed lower limb fractures; * history of lower limb surgery within 3 months; * lower limb pain caused by other diseases (such as lumbar disease, vascular disease, etc.); * speech and cognitive impairment * other diseases that cannot participate in this study.
overweight, obesity and weight variation among incarcerated women in french guiana: a study of factors associated with weight gain

Conditions: Obesity; Overweight

Summary: overweight and obesity are a public health issue, given the morbi-mortality they entail: increase in chronic diseases such as cardiovascular disease, diabetes, musculoskeletal disorders, certain cancers. according to the 2019 european health survey, french guiana has a high rate of overweight and obesity, affecting 51% of its population (compared with 47% in mainland france), with a higher prevalence among women (23%), this phenomenon being partly attributed to unfavorable eating habits and a sedentary lifestyle. another study in french guiana showed that 54.7% of those surveyed were overweight or obese, with a higher risk of obesity among single women, often from non-french caribbean and south american immigrant backgrounds, unemployed or poorly educated. some of these risk factors are found in the general prison population: immigrant population, unemployed, low socio-educational level. a meta-analysis published in 2017 analyzed weight variations in individuals during their period of incarceration. all but one study reported an increase in bmi and weight gain, in a significant proportion of participants. weight gain was associated with gender, and was higher in women. a systematic review of 2020 on cardiovascular risks associated with incarceration revealed, through meta-regression, a mean weight increase of 5.3 kg (ci95%: 0.5 to 10.1) and a variation in body mass index (bmi) of 1.8 kg/m2 (ci95%: -0.9 to 4.6) after two years of incarceration, attributed to a sedentary lifestyle, inappropriate diet, forced smoking cessation, use of psychotropic medication and high levels of stress. the higher prevalence of obesity among women is a trend observed both in french guiana and in the prison environment, where weight gain is associated with the female gender. there are currently no studies examining the weight of female prisoners in french guiana, its evolution and the identification of risk factors linked to weight gain in the cpg.


Eligibility criteria:
inclusion criteria: female adult in prison for more than 7 days at the time of the interviews exclusion criteria: * refusal to participate * cognitive impairment or lack of communication resulting in inability to complete questionnaire
multicomponent intervention on lifestyle, anthropometric measurements, glycemic control and quality of life in patients obese people with type ii diabetes

Conditions: Obesity; Diabetes Mellitus, Type 2

Summary: the main objective of this study will be to evaluate the effectiveness of a multicomponent intervention on nutritional recommendations and physical activity on glycemic control in obese patients with type ii diabetes (dm2) in three places at the algodonera health center of the care management integrated in talavera de la reina.

diabetes mellitus (dm) is a chronic process that is not only important for its incidence and prevalence, but also for its complications. dm is responsible for cardiovascular complications that have high and premature mortality and a significant impact on quality of life. diet control is one of the most effective therapeutic measures at all stages of diabetes management. it is important to promote healthy eating patterns that increase the consumption of foods with high nutritional value, in appropriate proportions, to improve overall health. the objective of this study will be to evaluate the effectiveness of a multicomponent intervention on nutritional recommendations and physical activity on glycemic control in obese patients with type ii diabetes (dm2) in three places at the algodonera health center of the integrated care management. from talavera de la reina. for this purpose, a clinical trial will be carried out with two parallel arms, random assignment and blind evaluation by third parties. the study will be carried out on obese patients with dm2 between 40 and 75 years old at the "algodonera" health center of the integrated care management of talavera de la reina over a period of 1 year, from the subject's admission to the hospital. study until the last follow-up evaluation at one year. selected patients must have a barthel index \> 90 and must travel to the health center independently.

Eligibility criteria:
inclusion criteria: * patients with a known diagnosis of dm2. * obese patients with a bmi \> 30. * patients with barthel index \> 90 * possibility of walking to the health center. * know how to read and write * that they agree to participate in the study and sign the informed consent. exclusion criteria: * patients with type i dm. * inability to perform physical exercise, defined as such, that appears in your current medical history or that your pcp considers. * patients with complete deafness. * patients with blindness. * moderate or severe cognitive impairment. * participation in another clinical trial. * pregnant or breastfeeding women * any condition, laboratory parameter or concomitant therapy that, in the opinion of the investigator, may be a risk to the potential participant or that participation in the study is not in the best interest of the patient.

Keywords: prevention clinical trial obesity diabetes mellitus, type 2 healthy lifestyle